Clinical trial • Phase II • Dermatology

KT-621 for Moderate to severe atopic dermatitis|Atopic dermatitis

Phase II trial of KT-621 for Moderate to severe atopic dermatitis|Atopic dermatitis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Moderate to severe atopic dermatitis|Atopic dermatitis
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-09-2025
First CTIS Authorization Date
13-01-2026

Trial design

Randomised, open-label, placebo: matching placebo administered daily in the double-blind, placebo-controlled (dbpc) treatment period to maintain blinding. active comparator arms: kt-621 administered orally once daily in multiple dose groups (described as x qd, y qd, z qd in the protocol; exact dose amounts not specified in available data). Phase II trial across 31 sites in Czechia, Germany, Poland.

Randomised
Yes
Open Label
Yes
Comparator
Placebo: matching placebo administered daily in the Double-blind, Placebo-controlled (DBPC) Treatment Period to maintain blinding. Active comparator arms: KT-621 administered orally once daily in multiple dose groups (described as X QD, Y QD, Z QD in the protocol; exact dose amounts not specified in available data).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
92
Trial Duration For Participant
476

Eligibility

Recruits 92 The trial selected a vulnerable population (isVulnerablePopulationSelected: true). Informed consent is required from participants via the Informed Consent Form (ICF). No specific assent or surrogate consent procedures for minors are described in the available documents..

Vulnerable Population
The trial selected a vulnerable population (isVulnerablePopulationSelected: true). Informed consent is required from participants via the Informed Consent Form (ICF). No specific assent or surrogate consent procedures for minors are described in the available documents.

Inclusion criteria

  • {"criterion_text":"- • 18 to 75 years of age, inclusive, at the time of signing the Informed Consent Form (ICF)\n- • Chronic AD (as defined by Hanifin and Rajka [Hanifin, 1980]) that has been present for at least 3 years before the Screening visit\n- • EASI score ≥ 16 at the Screening and Baseline visit\n- • vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits\n- • At least 10% BSA of AD involvement at the Screening and Baseline visits\n- • Weekly average Peak Pruritus NRS ≥ 4 at the Baseline visit\n- • Documented history within the 6 months prior to the Baseline visit of either an inadequate response to, or contraindication to topical medications for the treatment of AD\n- • Application of a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit"}

Exclusion criteria

  • {"criterion_text":"- • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks prior to Baseline.\n- • Presence of other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments\n- • Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures\n- • Prohibited therapy received within a specified time frame prior to the Baseline visit\n- • History of inadequate response to any therapeutic agent targeting IL-4, IL-13, and/or the JAK-STAT pathway (eg, dupilumab, lebrikizumab, upadacitinib, abrocitinib) at approved doses."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- • Percentage change from baseline to Week 16 in the EASI score","definition_or_measurement_approach":"Percentage change from baseline to Week 16 measured using the EASI (Eczema Area and Severity Index) score."}

Secondary endpoints

  • {"endpoint_text":"- • Proportion of participants with EASI-50, EASI-75, and EASI-90 at Week 16","definition_or_measurement_approach":"Proportion of participants meeting EASI improvement thresholds (50/75/90) at Week 16 using EASI score."}
  • {"endpoint_text":"- • Proportion of participants who achieve a vIGA-AD score of 0 to 1 (on a 5-point scale) and a reduction from baseline of at least 2 points at Week 16","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0–1 and ≥2-point reduction from baseline at Week 16 measured by vIGA-AD."}
  • {"endpoint_text":"- • Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16","definition_or_measurement_approach":"Proportion with ≥4-point improvement in Peak Pruritus Numeric Rating Scale (NRS) at Week 16."}
  • {"endpoint_text":"- •Incidence of TEAEs through Week 16","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent adverse events (TEAEs) observed through Week 16."}
  • {"endpoint_text":"- • Incidence of treatment-emergent SAEs through Week 16","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent serious adverse events (SAEs) through Week 16."}
  • {"endpoint_text":"- • Incidence of TEAEs from Week 16 through Week 68","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events recorded from Week 16 through Week 68."}
  • {"endpoint_text":"- • Incidence of treatment-emergent SAEs from Week 16 through Week 68","definition_or_measurement_approach":"Incidence of treatment-emergent serious adverse events recorded from Week 16 through Week 68."}
  • {"endpoint_text":"- • Plasma PK parameter estimates of KT-621 derived from plasma concentration time data to Week 16 and Week 68","definition_or_measurement_approach":"Plasma pharmacokinetic parameter estimates derived from plasma concentration–time data up to Week 16 and Week 68."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
92
Recruitment Window Months
27
Consent Approach
Informed consent is obtained from participants via a Main ICF and associated ICF variants. ICFs and recruitment information are available in country-specific languages (Czech, German, Polish). Additional informed consent documents are provided for prescreening, pregnant participants/pregnant partners, optional future research, and genetic testing. Consent is provided by participants (study enrolment requires signature of the ICF); no assent/parental consent processes for minors are described (study includes adults 18+).

Methods

  • Country-specific recruitment materials (posters, recruitment brochures, patient invitation letters, trial listings) provided for Czechia, Germany, and Poland.
  • Digital channels: social media posts and study information videos (country-specific) for public-facing recruitment.
  • Site-based recruitment using site prescreeners and prescreening ICFs.
  • Content creation and prescreener materials prepared by vendor partners (e.g., Proofpilot, Siteworks) to support recruitment.

Geography

Total Number Of Sites
31
Total Number Of Participants
108

Czechia

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
32

Sites

Site Name
Praglandia s.r.o.
Contact Person Name
Andrea Vocilková
Contact Person Email
a.voc@praglandia.cz
Site Name
Clintrial s.r.o.
Contact Person Name
Otakar Komárek
Contact Person Email
o.komarek@clintrial.cz
Site Name
Pratia Pardubice a.s.
Contact Person Name
Andrea Bartlová

Germany

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
79
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Sascha Gerdes
Site Name
Derma-Study-Center Friedrichshafen GmbH
Contact Person Name
Peter Radny
Contact Person Email
radny@dsc-fn.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten Zentrale Studienkoordination für innovative Dermatologie (ZID)
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Danielle Franziska Rogner
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Contact Person Name
Andrea Bauer
Contact Person Email
andrea.bauer@ukdd.de
Site Name
BAG Drs. med. Quist PartG
Contact Person Name
Sven Quist
Contact Person Email
s.quist@dermatologie-quist.de
Site Name
Hautarztpraxis Dr. Mihaescu
Contact Person Name
Virgil-Oreste Mihaescu
Contact Person Email
virgil.mihaescu@dr-mihaescu.de
Site Name
Siteworks GmbH
Department Name
Prüfzentrum Lohne Angegliedert an die Hautarztpraxis Dr. med. K. Hoffmann
Contact Person Name
Karl Hoffmann
Contact Person Email
hoffmann@siteworks-research.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Department of Dermatology
Contact Person Name
Athansios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Goethe University Frankfurt
Department Name
Klinik für Dermatologie, Venerologie und Allergologie, Klinische Forschung
Contact Person Name
Andreas Pinter
Contact Person Email
Pinter-klifo-ffm@gmx.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik f. Dermatologie, VenerologieAbt. Allergologie & lmmunologie, Rahel-Hirsch-Weg 2, Ebene 03
Contact Person Name
Margitta Worm
Contact Person Email
margitta.worm@charite.de

Poland

Earliest CTIS Part Ii Submission Date
22-12-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
81
Number Of Sites
17
Number Of Participants
57

Sites

Site Name
Dermed Centrum Medyczne Sp. z o.o.
Contact Person Name
Aleksandra Kaszuba
Contact Person Email
akaszuba@op.pl
Site Name
Synexus Polska Sp. z o.o. (Gdansk)
Contact Person Name
Karolina Osiecka
Contact Person Email
karolina.osiecka3@trialmed.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Joanna Kolinek
Site Name
Synexus Polska Sp. z o.o. (Gdynia)
Department Name
Synexus Polska Sp. z o.o. Oddzial w Gdańsku
Contact Person Name
Aneta Drożdzewska
Contact Person Email
aneta.drozdzewska@trialmed.com
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Contact Person Name
Jacek Szepietowski
Site Name
M2M Med. Sp. z o.o. Sp. j.
Contact Person Name
Magdalena Kolanko
Contact Person Email
kolankomagdalena@gmail.com
Site Name
Etg Warszawa Sp. z o.o.
Contact Person Name
Maria Zegadlo-Mylik
Contact Person Email
m.zegadlomylik@etg-network.com
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Tadeusz Dębniak
Contact Person Email
principal@klinikaambroziak.pl
Site Name
Diamond Clinic Sp. z o.o. (Cracow)
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Beata Imko-Walczuk
Contact Person Email
bimko@wp.pl
Site Name
Synexus Polska Sp. z o.o. (Wroclaw)
Contact Person Name
Tomasz Kołodziej
Contact Person Email
bimko@wp.pl
Site Name
Diamond Clinic Sp. z o.o. (Cracow, U11)
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Contact Person Name
Michał Adamczyk
Contact Person Email
michaladamczyk1310@wp.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Contact Person Name
Bartłomiej Kwiek
Contact Person Email
principal@klinikaambroziak.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Klinika Dermatologii i Dermatologii Onkologicznej
Contact Person Name
Adam Reich
Contact Person Email
adi_medicalis@go2.pl
Site Name
Diamond Clinic Sp. z o.o. (Cracow, U14)
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu

Sponsor

Primary sponsor

Full Name
Kymera Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
WCG Clinical Inc.
Responsibilities
Rater Training
Name
PPD Development LP
Responsibilities
Multiple responsibilities (codes provided in source: 1,12,13,2,4,5,8,9)
Name
Suvoda LLC
Responsibilities
Clinical trial technology / eClinical (responsibility code provided)
Name
Medidata Solutions Inc.
Responsibilities
Clinical data platform support (responsibility code provided)

Third parties

  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Rater Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"COA & ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Proofpilot Inc.","duties_or_roles":"Content Creation: Prescreener, Study Microdite, Partner Materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Digital Medical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Quantificare","duties_or_roles":"Photographs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Codes: 1,12,13,2,4,5,8,9 (responsibility codes listed in source)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"Medicinal product management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Payments","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
KT-621
Active Substance
KT-621
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Frequency
Once daily (QD) described; exact schedule: once daily
Investigational Product Name
Placebo (matching)
Modality
Other
Frequency
Daily (matching study drug)

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